510(k) · Cleared
ClearedNSK Precision Apex Locator (Pal)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicsense USA · LQY Locator, Root Apex
Cleared on Jan 24, 2006 as substantially equivalent to K032743 (Medicnrg, Ltd., 2004) after a 67-day review. Its family tree reaches back 4 generations to 1993.
- Decided
- Jan 24, 2006
- Review
- 67 days
- Class
- Class U
- Product code
- LQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921979 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK921979 Root ZXJ. Morita USA, Inc. · 1993
- 3 generations backK972407 Root Apex LocatorToei Electric Co., Ltd. · 1997
- 2 generations backK022020 Justwo Model Tme-601 Root Apex LocatorToei Electric Co., Ltd. · 2002
- 1 generation backK032743 Apex NRGMedicnrg, Ltd. · 2004
- This deviceK053235 NSK Precision Apex Locator (Pal)Medicsense USA · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921979 | Root ZX | J. Morita USA, Inc. | 1993 | — |
| −3 | K972407 | Root Apex Locator | Toei Electric Co., Ltd. | 1997 | — |
| −2 | K022020 | Justwo Model Tme-601 Root Apex Locator | Toei Electric Co., Ltd. | 2002 | — |
| −1 | K032743 | Apex NRG | Medicnrg, Ltd. | 2004 | — |
| 0 (this device) | K053235 | NSK Precision Apex Locator (Pal) | Medicsense USA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LQY device
- #1 K252224 Apex Locator (FindPex)score 12.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032743 | Apex NRGSummary page 1…x, Class 2, Product Code LQY, unclassified Name: NSK Precision Apex Locator (PAL) 3. Predicate Device: MedicNRG Electronic Apex Locator (K032743) 4. Description: The NSK Precision Apex Locator is a dental medical device which has the… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K032743.
How does its category compare?
All LQY devicesLQY Locator, Root Apex: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LQY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LQY
164in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LQY
No recall names LQY since 2007.
Adverse event reports per year · LQY
51in 2025
MAUDE reports naming product code LQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 15 |
| 2010 | 3 | 164 | 0 | 22 |
| 2011 | 2 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 59 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 1 | — | 0 | 128 |
| 2017 | 0 | — | 0 | 133 |
| 2018 | 2 | — | 0 | 154 |
| 2019 | 1 | — | 0 | 163 |
| 2020 | 0 | — | 0 | 139 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 1 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 56 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 51 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The NSK Precision Apex Locator is intended for the measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053235: NSK Precision Apex Locator (Pal).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053235
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026